Steripath Micro Blood Collection System

Set, Administration, Intravascular

Magnolia Medical Technologies Inc.

The following data is part of a premarket notification filed by Magnolia Medical Technologies Inc. with the FDA for Steripath Micro Blood Collection System.

Pre-market Notification Details

Device IDK200661
510k NumberK200661
Device Name:Steripath Micro Blood Collection System
ClassificationSet, Administration, Intravascular
Applicant Magnolia Medical Technologies Inc. 200 West Mercer Street, Suite 500 Seattle,  WA  98119
ContactGregory J. Bullington
CorrespondentGregory J. Bullington
Magnolia Medical Technologies Inc. 200 West Mercer Street, Suite 500 Seattle,  WA  98119
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-12
Decision Date2020-10-08

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